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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 26G 6MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR

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REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 26G 6MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
Patient's mother to schedule refill order of hizentra and supplies. She informed patient experiences pain with needle sets that we provide. She said there is "a plastic in the middle of it that digs into his skin" leaving it irritated. She advised his previous dispensing pharmacy sent needle sets that did not cause so much irritation. I transferred her to a pharmacist to assist with providing an alternate product. Unknown if pt missed a dose; unknown if available for return; unknown lot number. No further information known. Indication: antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameIV SCIG 26G 6MM HIGH FLO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
MDR Report Key12481148
MDR Text Key272122653
Report NumberMW5103991
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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